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Patients are dying because drugs used in Europe and the United States are not immediately available in Japan. The situation cannot be overlooked. The government must resolve the problem as soon as possible.
The time it takes for foreign drugs to become available in Japan — dubbed a “drug lag” — has become a problem. It is particularly serious for pediatric patients suffering from intractable diseases that afflict only a small number of children.
The gulf between Japan and Western countries, where advanced genetic analysis technology has led to the emergence of many new drugs, has become particularly more conspicuous in recent years especially among pediatric cancer patients.
In the case of the new neuroblastoma drug Unituxin, which was approved in some Western countries in 2015, approval in Japan came six years later in 2021.
Approval of a drug requires confirmation of its efficacy and safety through clinical trials, but in the case of Unituxin, Japan was not selected as a participating country in the joint clinical trials conducted in several countries.
As a result, Japanese doctors had to conduct clinical trials on their own. It took a long time to obtain results due to a shortage of manpower and funds, and the application for approval could not be submitted until 2020. Some patients died during this period. It is quite regrettable, but such cases are not uncommon in Japan.
It is necessary to address the reasons why Japan is often not selected as a participant in international clinical trials. Factors cited include claims that patients are scattered across many hospitals, making it difficult to recruit participants, and a lack of personnel who can speak foreign languages.
The government needs to consider ways to achieve a breakthrough in cooperation with the medical community and the pharmaceutical industry.
In the first place, the development of pediatric drugs is a difficult field for pharmaceutical companies to enter. It is difficult for pharmaceutical companies to generate profits commensurate with costs because of the low number of pediatric patients and the requirement of special considerations, such as the fact that drug dosage and administration differ from those for adults. This has been a common challenge worldwide.
Even so, many new drugs have been approved in Western countries because of system reforms. It is vital to establish such systems in Japan.
In Western countries, when companies conduct clinical trials for a drug for adults, they are obliged to carry out clinical trials for children. The system is also designed to benefit companies.
In the United States, companies that have engaged in the development of pediatric drugs that affect a small number of patients are entitled to priority screening when seeking approval for other drugs, thereby shortening approval periods. Thanks in part to such a system, 34 new drugs for childhood cancer have been developed since 2017.
The Health, Labor and Welfare Ministry has reportedly set up a research group to study overseas systems for pediatric drugs and is analyzing issues involved in introducing such systems in Japan. The ministry must determine what kind of system will be effective in Japan and implement it.
